title: Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs.
abstract: Regulatory recommendations for providing bioanalytical support for biological therapeutics have co-evolved with the increasing success of these unique pharmaceuticals. Immunoassays have been used to quantify biological macromolecules for more than 50 years. These assays rely on the use of antigen-specific antibodies. More recently, LC-MS methods have being adapted to quantitate biologics. LC-MS has attributes that complement the limitations encountered by immunoassays. Whether employing immunoassay or LC-MS methods, compared with traditional chemical-based therapeutics, biological therapeutics present unique analytical challenges to analysts. In this article, we review bioanalytical strategies for supporting biologics and discuss the regulatory and analytical challenges that must be met.
authors.affiliation: Worldwide Clinical Trials, Drug Development Solutions, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA. william.nowatzke @wwctrials.com
authors.forename: William L
authors.initials: WL
authors.lastname: Nowatzke
authors.forename: Kathryn
authors.initials: K
authors.lastname: Rogers
authors.forename: Edward
authors.initials: E
authors.lastname: Wells
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Bowsher
authors.forename: Chad
authors.initials: C
authors.lastname: Ray
authors.forename: Steve
authors.initials: S
authors.lastname: Unger
mesh_terms: D002853:Chromatography, Liquid; D006801:Humans; D007118:Immunoassay; D046911:Macromolecular Substances / Q000032:analysis* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D010455:Peptides / Q000032:analysis / Q000493:pharmacokinetics / Q000627:therapeutic use; D011506:Proteins / Q000032:analysis / Q000493:pharmacokinetics / Q000627:therapeutic use; D053719:Tandem Mass Spectrometry
chemical_list: D046911:Macromolecular Substances; D010455:Peptides; D011506:Proteins